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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Pneumatic
510(k) Number K061297
Device Name ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
Applicant
The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact JAMES CARBONE
Correspondent
The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact JAMES CARBONE
Regulation Number882.4370
Classification Product Code
HBB  
Date Received05/09/2006
Decision Date 01/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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